From Clinical Trial Villains to Heroes; a Look at the Industry with Débora Araujo

This is an excerpt from Longboat's downloadable interview series "Expert Opinions: How the Clinical Trial Industry Needs to Evolve?" featuring full interviews with high-impact leaders from the clinical research world. To access the full interview series, click here.

Meet the Interviewee: Débora Araujo, founder of ClinBiz, and author.

After 13 years working on contracting, financial management and operations for pharma companies including Novartis, Déborawanted to share her knowledge and practical experience with others. She wrote a bestselling book, The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them and founded ClinBiz – an online platform and community where clinical research professionals connect, share best practice and learn about the business aspects of clinical trials.

What inspired you to write a book about clinical trial contract negotiation?

Sometimes we think that we need to be so far along in our career to be able to help others. But often what you know is already so much more than those starting out or entering a new area may know, and they may really be helped by your experience. The idea was to provide something very practical to help people understand how to speed things up in clinical contract negotiation which is a big pain point in our industry.

Without giving all the detail away, who are the four villains you talk about?

The villains are the four main things that really delay our clinical contract negotiations. One of them is CRO-managed negotiation, where sponsors hire a CRO to negotiate on their behalf. Some of those go very well, and some of them just go down the drain.

The second villain is ineffective site budget negotiation. When we say site contract negotiations that includes the legal language and the budget, but the budget fees negotiation is such a huge part of that negotiation that we need to tackle that separately.

The third villain is a painful truth. It’s the lack of industry adoption and innovation. And then our fourth villain is all the other things that can affect CTA negotiations, which we call Mr Peripheral. The book is very practical. I think if you're able to implement one or two suggestions, it can really help sponsors move things along and there are tips for the research site on what they can do to speed up negotiations too.

Alongside that, you set up the ClinBiz community – how did that begin? I wanted to translate all those years in the pharma world into something a little more practical for people who want to learn more in this area. It’s a real grassroots community of clinical trial professionals. We began with the YouTube channel, a podcast, and a blog, and we now have online courses and an annual conference coming up in March.

What are the things that people ask you about most frequently in the ClinBiz community?

The question that we most get is ‘what are my peers doing around site budget negotiations and costs?’ People are keen to learn what others in the industry are doing in terms of best practice. That’s exactly why we built ClinBiz. I’m privileged to be able to get out to conferences, where you get a bunch of information and to share best practices. But I noticed that most people in the industry are not able to attend conferences on an ongoing basis, for budget or other reasons.

From January 2019 we’ll offer online courses on these topics so people are able to still develop themselves from wherever they are. We’ve also created the option to access the ClinBiz summit via Livestream for those who cannot come onsite. This is very new to our industry and I hope it catches on to others.

You’ve worked on both the sponsor and site’s team side. How did that experience help shape the book and the ClinBiz platform?

Spending that time in the research site was absolutely eye-opening because I was responsible for the same areas as I was on the sponsor side through the years, which was site budget, development, and negotiations – but from the site perspective. I was able to see the reasons why sites were asking for certain costs to be covered, where the pain points were in terms of investigators’ site payments, the delays, and the impact of those delays. I saw certain things the sponsors were doing that were redundant, and I also saw where sponsors were doing the right things that were working well from a site perspective and should perhaps be multiplied across the industry. It was a blessing to have seen it through that lens.

What are the implications of the delays and pain points that you mention?

They have a really big impact on the people at the heart of our whole industry - the patient. In fact, the foreword of the book was written by T.J. Sharpe, a patient advocate who in 2012 was diagnosed with stage IV melanoma yet was delayed from entering a clinical trial because of a contract delay. It’s one of those things we don’t tend to think about – especially people who are immersed in the business or administrative aspect of clinical trials day in and day out. It may seem after a while that we’re simply doing paperwork. We may be on the research site or sponsor side, but at the end of the day we’re all moving in the same direction. If we can solve those small issues that have big impact, I think that’s a huge step forward.

What do you think are the solutions?

Standardization is definitely a big deal. In terms of contracting, every sponsor and every site is using a different template, using a different language. It’s a big hurdle. Because of the competitive nature of our industry, it’s hard to get it standardized. But even if we were able to standardize a few things within contracting, outsourcing, payments and so on, it would help.

Technology is another solution, especially for site payments. Sponsors having better technologies in place to be able to automate those payments – it’s low-hanging fruit. There are other technology advancements around contracting available now, which are very exciting, and simply need to be adopted. And then there are exciting new developments around outsourcing management processes like request for proposals (RFPs). We’ll be sharing some of these advances at the ClinBiz summit. The industry is innovating a lot in these areas in the last two years and it’s really exciting to see it coming to life.

Thinking about the villains, how many of them come down to relationships and communication?

All of them. At the very base of it is communication across different stakeholders. Sites don’t get to see a lot of the things that go on at sponsor level, so we hope to unveil a couple of questions around that. It’s also important for sponsors to understand more and more what is going on in their negotiations. Because each site is really different, especially in the US. The communication is extremely important. Otherwise, we all get left in our little silos and continue to do things year after year which we think are great but don’t solve anything.

I think there’s a lot that we can share between sponsors and sites. There are a lot of things that are non-confidential and especially if you're within the scope of a study where everyone has already signed confidentiality agreements. It can be very helpful to have one platform where people are able to provide input and are able to see what’s happening in real time, because then decisions can be reached much quicker.

How do you predict the clinical trial environment will change within the next decade?

I think digital remote trials are going to take centre stage. We’re still in the stage of learning a lot and finding our way with these. We may or may not see fewer research sites due to these trials, but the way work is conducted at the research site is certainly going to change. People need to be ready to change with it whether they’re sponsors or sites.

How do you predict the clinical trial environment will change within the next decade?

I think digital remote trials are going to take centre stage. We’re still in the stage of learning a lot and finding our way with these. We may or may not see fewer research sites due to these trials, but the way work is conducted at the research site is certainly going to change. People need to be ready to change with it whether they’re sponsors or sites.

From my perspective, through the lens of the business aspect of trials, having the stakeholders come together and agree on more standardization across the board is something I would like to see. Whether that begins with sponsors or research sites, I think if we could come together and try to standardize more using technology and aligned processes it would help move things faster. We need to be okay with laying aside our individuality when things are not working. I’m all for keeping individuality where processes are adding great value. But I think we really need to agree on areas where we can come together so that we can move things forward in this space a little more.

This is an excerpt from Longboat's downloadable interview series "Expert Opinions: How the Clinical Trial Industry Needs to Evolve?" featuring full interviews with high-impact leaders from the clinical research world. To access the full interview series, click here.